The Bio-SHiFT study aims to investigate whether disease progression in individual patients with chronic heart failure (CHF) can be accurately assessed by serial measurements of disease-related (novel) biomarkers. Secondary objectives of the study include comparison of 2D- with real-time 3D-echocardiography in CHF patients and comparison of Speckle tracking with tissue Doppler imaging (TDI) in CHF patients, and relating these echocardiographic measurements to clinical outcome.

Bio-SHiFT is a prospective, observational, multi-center, cohort study in men and women, aged 18 years or older, visiting the outpatient clinic. Blood samples are taken at the day of inclusion and at follow-up visits, which are performed every 3 months until the end of the scheduled follow-up. Clinical data are collected at baseline and at each 3-month follow-up visit. Echocardiography including TDI, Speckle tracking and 3D-echocardiography is performed in a subset of patients, at baseline and during follow-up at 6-month intervals. The primary endpoint is the composite of cardiovascular death, cardiac transplantation, left ventricular assist device implantation, and re-hospitalization for the management of acute or worsened heart failure.

The composite of cardiovascular death, cardiac transplantation, left ventricular assist device implantation, and re-hospitalization for the management of acute or worsened heart failure. [ Time Frame: maximum follow-up is 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cardiovascular death [ Time Frame: maximum follow-up is 2.5 years ] [ Designated as safety issue: No ]

Blood (EDTA plasma, citrate plasma, serum, DNA) and urine samples are taken at the day of inclusion and at follow-up visits, which will be performed every 3 months, until the end of the scheduled follow-up, or until the patient dies. The maximum total number of samples per patient is 11 (in patients with 30 months follow-up).

Men and women, aged 18 years or older, capable of understanding and signing informed consent

Diagnosis of chronic heart failure (with diminished ejection fraction or with normal ejection fraction), according to the guidelines of the European Society of Cardiology (ESC)

Exclusion Criteria:

Heart failure secondary to circulatory high output conditions

Scheduled for surgery or intervention for both coronary and non-coronary indication

Severe renal failure for which dialysis is needed

Known moderate or severe liver disease

Chronic Obstructive Pulmonary Disease (COPD) Gold stage IV

Congenital heart disease

Coexistent condition with life expectancy ≤ 1 year

Unlikely to appear at all scheduled follow-up visits

Linguistic barrier

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01851538